Ibuprofen Tablet
FDA Recall NDC 25000-114
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ibuprofen (NDC 25000-114). A significant event, classified as Class II, was initiated on Jan 09, 2018 by Marksans Pharma Limited. The reported reason for this action was: "CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Jan 09, 2018
Jan 31, 2018
2,853,500 Caplets
Recall Profile & Regulatory Data
Event ID
78822
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Marksans Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Termination Date
May 26, 2020
Product Description
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.
Batch or Lot Expiration Information
Lot# : HH6001, HH6002, Exp 04/18
Affected Packages Involved in this Recall
25000-114-03Product
25000-114-14Product
25000-114-20Product
25000-114-30Product
25000-114-98Product
25000-114-93Product
25000-114-70Product
25000-114-71Product
25000-114-02Product
25000-117-03Product
25000-117-14Product
25000-117-20Product
25000-117-30Product
25000-117-98Product
25000-117-93Product
25000-117-69Product
25000-117-02Product
Class II Terminated
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Jan 09, 2018
Jan 31, 2018
205,088,000 tablets
Recall Profile & Regulatory Data
Event ID
78822
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Marksans Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Termination Date
May 26, 2020
Product Description
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.
Batch or Lot Expiration Information
Lot# : HJ6080, HJ6081, HJ6082, HJ6083, HJ6084, HJ6085, HJ6086, HJ6087, HJ6088, HJ6089, HJ6090, HJ6091, HJ6092, HJ6093, HJ6094, HJ6095, HJ6096, HJ6097, HJ6098, HJ6099, HJ6100, HJ6101, HJ6102, HJ6103, HJ6104, HJ6105, HJ6106, HJ6107, HJ6108, HJ6109, HJ6110, HJ6111, HJ6112, Exp 02/18; HJ6113, HJ6114, HJ6115, HJ6116, HJ6117, HJ6118, HJ6119, HJ6120, HJ6121, HJ6122, HJ6123, HJ6124, HJ6125, HJ6126, HJ6127, HJ6128, HJ6129, HJ6130, HJ6131, HJ6132, HJ6133, HJ6134, HJ6135, HJ6136, Exp 03/18; HJ6137, HJ6138, HJ6139, HJ6140, HJ6141, HJ6142, HJ6143, HJ6144, HJ6145, HJ6146, HJ6147, HJ6148, HJ6149, HJ6150, HJ6151, HJ6152, HJ6143, HJ6154, HJ6155, HJ6156, HJ6157, HJ6158, HJ6159, HJ6160, HJ6161, HJ6162, HJ6163, HJ6164, HJ6165, HJ6166, HJ6167, HJ6168, HJ6169, HJ6180, HJ6171, HJ6172, HJ6173, HJ6174, HJ6175, Exp 04/18; HJ6176, HJ6177, HJ6178, HJ6179, HJ6180, HJ6181, HJ6182, HJ6183, HJ6184, HJ6185, HJ6186, HJ6187, HJ6188, HJ6189, HJ6190, HJ6191, HJ6192, HJ6193, HJ6194, HJ6195, HJ6196, HJ6197, HJ6198, HJ6199, HJ6200, HJ6201, HJ6202, HJ6203, Exp 05/18; HJ6204, HJ6025, HJ6206, HJ6207, HJ6208, HJ6209, HJ6210, HJ6211, HJ6212, HJ6213, HJ6214, HJ6215, Exp 06/18; HJ6216, HJ6217, HJ6218, HJ6219, HJ6220, Exp 08/18
Affected Packages Involved in this Recall
25000-114-03Product
25000-114-14Product
25000-114-20Product
25000-114-30Product
25000-114-98Product
25000-114-93Product
25000-114-70Product
25000-114-71Product
25000-114-02Product
25000-117-03Product
25000-117-14Product
25000-117-20Product
25000-117-30Product
25000-117-98Product
25000-117-93Product
25000-117-69Product
25000-117-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
